To be included in this study, patients should complete all screening procedures and meet all of the following criteria:
Males 18 years of age and above
Histologically or cytologically proven diagnosis of prostate adenocarcinoma
High-risk disease defined as at least one of the following factors:
Gleason ≥8
PSA ≥20 ng/mL
T3/T4 disease
ECOG Performance status of 0 or 1 (Appendix A: Performance Status Criteria)
Patients deemed appropriate candidates for radical prostatectomy
Baseline blood pressure \<160 x 100 mmHg
Normal hematologic, liver, and renal functions
Absence of any contraindications for darolutamide use
Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
Baseline testosterone of 200 ng/dL or more
Normal organ function with acceptable initial laboratory values within 14 days of treatment start: Match lab values to those scheduled in Table 1.
ANC • \> 1,500/µl
Hemoglobin • \> 9g/dL
Platelet count • \> 100,000/µl
Creatinine • ≤ 1.5 x the institutional upper limit of normal (ULN)
Potassium • \> 3.5 mmol/L (within institutional normal range)
Abiraterone acetate, TAK-700 or other CYP17 inhibitors
Systemic ketoconazole
Any drug listed in Appendix C
Patients on current treatment for a second malignancy (except for Ta bladder urothelial carcinoma or non-melanoma skin cancer).
Uncontrolled hypertension (defined as systolic blood pressure of 150 mmHg or higher; diastolic blood pressure of 100 mmHg or higher in 2 or more measurements) or uncompensated cardiac disease (NYHA III or IV)
Known allergy, hypersensitivity, any other contraindications to the compounds under investigation (darolutamide or PSMA radiotracers)
Clareo Health | A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer
